Servicio de Cardiología, Hospital Universitario La Paz, IdiPAZ, Spain.
Hospital German Trias i Pujol, Badalona, Spain.
Catheter Cardiovasc Interv. 2024 May;103(6):1015-1022. doi: 10.1002/ccd.31032. Epub 2024 Apr 5.
Previous studies have documented a high rate of implantation success with the ACURATE neo2 valve, as well as a reduction in paravalvular leak (PVL) compared to its predecessor, the ACURATE neo. However, there are no studies that have reviewed and compared the long-term clinical and hemodynamic outcomes of these patients.
This study aimed to evaluate the results of the ACURATE neo transcatheter aortic valve in a real-world context, and to compare the results of the outcomes of both generations of this device (ACURATE neo and ACURATE neo2), with a specific focus on procedural success, safety, and long-term effectiveness.
A prospective study including all consecutive patients treated with the ACURATE neo device in seven hospitals was conducted (Clinical Trials Identification Number: NCT03846557). The primary endpoint consisted of a composite of adverse events, including mortality, aortic insufficiency, and other procedural complications. As the second-generation device (ACURATE neo2) replaced the ACURATE neo during the study period, hemodynamic and clinical results before admission, at 30 days, and at 1 year of follow-up were compared between the two generations.
A total of 296 patients underwent transcatheter aortic valve implantation with the ACURATE device, with 178 patients receiving the ACURATE neo and 118 patients receiving the ACURATE neo2. In the overall population, the absence of device success occurred in 14.5%. The primary reason for the absence of device success was the presence of para-valvular regurgitation ≥ 2. There were no instances of coronary occlusions, valve embolization, annulus rupture, or procedural deaths. ACURATE neo2 was associated with a significantly higher device success rate (91.7% vs. 82%, p = 0.04), primarily due to a significantly lower rate of para-valvular regurgitation, which remained significant at 1 year.
The use of ACURATE neo and neo2 transcatheter aortic valves is associated with satisfactory clinical results and an extremely low rate of complications. The ACURATE neo2 enables a significantly higher device success rate, primarily attributed to a significant reduction in the rate of PVL.
先前的研究已经证明，ACURATE neo2 瓣膜的植入成功率很高，与前代瓣膜 ACURATE neo 相比，瓣周漏（PVL）的发生率也有所降低。然而，目前尚无研究对这些患者的长期临床和血液动力学结果进行回顾和比较。
本研究旨在评估 ACURATE neo 经导管主动脉瓣在真实环境中的结果，并比较两代该器械（ACURATE neo 和 ACURATE neo2）的结果，重点关注手术成功率、安全性和长期效果。
进行了一项包括在七家医院接受 ACURATE neo 装置治疗的所有连续患者的前瞻性研究（临床试验识别号：NCT03846557）。主要终点由包括死亡率、主动脉瓣关闭不全和其他手术并发症的不良事件组成。由于第二代器械（ACURATE neo2）在研究期间取代了 ACURATE neo，因此比较了两代器械在入院前、术后 30 天和 1 年随访时的血液动力学和临床结果。
共有 296 例患者接受了 ACURATE 装置的经导管主动脉瓣植入术，其中 178 例患者接受了 ACURATE neo，118 例患者接受了 ACURATE neo2。在总体人群中，器械成功率缺失率为 14.5%。器械成功率缺失的主要原因是存在≥2 级的瓣周漏。没有发生冠状动脉闭塞、瓣膜栓塞、瓣环破裂或手术死亡。ACURATE neo2 与更高的器械成功率相关（91.7% vs. 82%，p=0.04），主要是由于瓣周漏的发生率显著降低，这一结果在 1 年时仍然显著。
使用 ACURATE neo 和 neo2 经导管主动脉瓣可获得满意的临床结果和极低的并发症发生率。ACURATE neo2 可显著提高器械成功率，主要归因于瓣周漏发生率的显著降低。
